Ignite Creation Date:
2024-05-05 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00580346
Status:
WITHDRAWN
Last Update Posted:
2022-07-21
First Post:
2007-12-21
Brief Title:
Dynamic Laryngotracheal Separation for Aspiration
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
Dynamic Laryngotracheal Separation for Aspiration Prevention of Silent Aspiration Pneumonia During Swallowing by an Implanted Stimulator
Status:
WITHDRAWN
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study never started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People who aspirate after neurologic insults such as stroke often develop fatal pneumonia This study examines the effects of dynamic vocal cord closure on swallowing Implants placed over the chest wall are connected to electrodes placed around the nerve that closes the vocal cords The patient triggers closure by flipping the switch of a coil taped over the skin covering the internal stimulator Vocal cord motion is verified by videotaping through an endoscope and the status of swallowing is documented radiologically by a modified barium swallow
Detailed Description:
Data pending
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IDE G980179 | None | None | None |
| NIH DC-006703-01 | None | None | None |